In its First Report of
Session 2007-2008, the House of Commons Health Select
Committee was clear: “NICE should not recommend
interventions when the evidence is weak” (Volume I:29)
but that is exactly what NICE did in its Clinical Guideline
on “CFS/ME” (CG53).

In alleged support of the
PACE trial and prior to selective results being published in
February 2011, the MRC conceded about CBT/GET that: “there
was a lack of high quality evidence to inform treatment of
CFS/ME and in particular on the need to evaluate
treatments that were already in use and for which there
was insufficiently strong evidence from random controlled
trials of their effectiveness” (Dr Frances Rawle,
Head of Corporate Governance and Policy, 6th
January 2011).

That is a astonishing
admission, since the NICE Clinical Guideline on “CFS/ME” of
22nd
August 2007 relied upon the pre-PACE Wessely School
“evidence-base” to recommend the use of CBT and GET
nationally as the intervention of choice, yet the MRC
confirmed – in writing -- that there was insufficient
evidence for the implementation of this nationwide programme
of CBT and GET recommended by NICE in its Clinical
Guideline, so NICE jumped the gun by four years.

The draft NICE Guideline

The same scenario of
“policy compliance” as existed in the RAG pertained
throughout the public consultation process and production of
the NICE Guideline on “CFS/ME” (CG53), but to a far greater
and more sinister degree:

- A “policy decision” was
taken by NICE not to consider any biomedical evidence that
disproved the psychosocial model. The NICE Guideline
Development Group (GDG) was specifically instructed not to
consider the totality of the published evidence on ME.

- GDG members who would
support “policy” were carefully chosen, and there was not a
single medical expert on ME/CFS on the GDG (an unheard-of
situation in the production of other NICE Guidelines, where
GDGs are replete with experts in the disease in question).
ME/CFS experts who requested to be on the GDG were
dismissively brushed aside, and even the application of the
Medical Advisor to the ME Association to be a member of the
GDG was refused.

- GDG members included
doctors who work for the permanent health insurance industry
(PHI) and who had a long track record of refusing legitimate
claims by asserting that “CFS/ME” is a behavioural (mental)
disorder and thus excluded from benefit; one such GDG
member, Dr William Hamilton, had spent 15 years working for
insurance companies and during production of the NICE
Guideline on “CFS” was Chief Medical Officer for at least
three such companies including Exeter Friendly Society,
Friends Provident and Liverpool Victoria Friendly Society.
Further, Hamilton had been funded by the Linbury Trust for
his work on “CFS/ME” (£58,992 to collaborate with Peter
White).

- One GDG member was
paediatrician Dr Esther Crawley, a committed Wessely School
supporter who was subsequently proven to exaggerate the
success of the PACE trial, publishing a paper in which she
claimed a success rate of up to 40% (when challenged, she
was unable to provide any evidence for her claim).

- Another GDG member was
an Occupational Health physician, Dr Julia Smedley, who
confirmed in writing that: “I do not treat patients with
CFS/ME”. Why was Dr Smedley even considered for the
GDG? She clearly had no day-to-day experience of the
disorder under discussion (a stated requirement for election
to the GDG).

- Other GDG members
included a dietician and a reflexologist/hypnotherapist, who
were chosen in preference to dedicated medical practitioners
who had devoted their whole career to the disorder.

- It was confirmed that
advisors to the GDG included Simon Wessely, Peter White and
Michael Sharpe.

- The Questionnaire sent
out for public consultation contained a serious “misprint”
relating to questions 29-61 (out of a total of 90
questions), making a nonsense of responses to those
questions and meaning that over one third of answers would
be likely to achieve results that respondents did not intend
but which would support the pre-determined outcome.

- The GDG relied on the
York Systematic Review of the CBT/GET literature, which was
shown to be flawed (see: “Inadequacy of the York (2005)
Systematic Review of the CFS/ME Medical Evidence Base:
Comments on Section 3 of ‘The diagnosis and management of
CFS/ME in adults and children: Work to support the NICE
Guidelines’ ” by Professor Malcolm Hooper and Horace Reid,
January 2006 – this academic review exposed the
ineffectiveness of CBT and the potential dangers of GET as
recorded by international researchers from the US, Canada,
Australia and New Zealand).

- Patients’ own evidence
was ignored, which perpetrated and even sanctioned the
culture of contempt surrounding CFS/ME; this was embedded in
the GDG’s decision not to accept CFS/ME as a physical
disorder (which was in defiance of the WHO international
classification of ME/CFS as a neurological disorder) and GDG
members even went so far as to state that if a patient
displayed abnormal neurological or cardiovascular features,
they did not have “CFS/ME”.

- The draft Report stated
categorically that “some will recover fully” and that
“there are no objective abnormalities”.

- “CFS/ME” was portrayed
as a somatisation disorder and the advice was that “the
concept of CFS (should be considered) through a
biopsychosocial model”, even though ME/CFS is a
formally classified nosological entity that is organic, not
psychosocial, in aetiology and nature.

- Of particular concern
was that the draft NICE Guideline stated: “Terminology
used by doctors such as ‘functional syndrome’ and
‘medically unexplained symptoms’ are part of common usage
in clinical practice today”, thereby sending out the
clear message that any doctor who did not subscribe to this
would run the risk of being ridiculed by his/her peers and
might even face sanctions.

- As anticipated, the
draft Guideline effectively proscribed laboratory testing
and focused only on CBT/GET as the interventions of choice.

- There were important
technical anomalies in the draft Guideline, including the
GDG’s failure to comply with the AGREE Instrument (Appraisal
of Guideline Research and Evaluation Instrument), especially
GDG members’ failure to declare any conflicts of interest;
the GDG’s failure to describe precisely the patients to whom
the Guideline was meant to apply, and the GDG’s absolute
failure to include individuals from all relevant
professional groups (the AGREE Instrument requires that NICE
was obliged to give equal weight to three main sources of
data: random controlled trials; the opinion and experience
of physicians with expertise in the area, and the opinion
and experience of the patient group for whom the Guideline
is intended).

In its response to the
draft Guideline, the ME Association said they were unwilling
to endorse it; that it contained numerous recommendations
which were based on opinion rather than on evidence-based
medicine which normally dominates a NICE guideline, and that
it was not fit for purpose: “We find it hard to imagine
another situation where a group of people, many of whom
have little or no direct experience in the clinical care
of an illness they are advising on, have produced such a
poor quality guideline”.

Also commenting on the
NICE draft Guideline, in his Stakeholder Comments on 26th
November 2006 Dr Neil Abbot, Director of Operations at the
charity ME Research UK (MERUK) said: “The draft produced
by the GDG is unsafe and unsatisfactory because it does
not engage with key issues involved in the diagnosis and
management of ME/CFS….It would be preferable for NICE and
the GDG to recognise that…evidence-based recommendations
for treatment cannot be made at present than to
incorporate an inadequate evidence base into…guidelines
which feed into clinical care and government policy to the
detriment of people with ME/CFS”.

Many other Stakeholders
submitted cogent criticisms (for more details, see
“Corporate Collusion?” by Malcolm Hooper, Eileen Marshall
and Margaret Williams, September 2007).

The finalised NICE Guideline on “CFS/ME”

In contravention of usual
practice, GDG members did not declare their competing
interests until two months after the final Guideline was
published.

The final Guideline was
like the proverbial Curate’s egg: good in parts. It
was clear that, to its credit, the Guideline Development
Group took heed of many submitted representations but that
the Wessely School retained control of the recommended
management strategies, although to nothing like the extent
they sought, and that even those management strategies (CBT
and GET) were modified from those previously employed by the
Wessely School (which sought to force patients to change
their beliefs and accept that they were not suffering from a
physical disorder, about which Dr Ellie Stein – herself a
psychiatrist -- said at the ME Research UK International
Conference in Edinburgh on 25th May 2007:“I
would never in my practice use the Wessely model of CBT –
I find it disrespectful to try to convince somebody they
don’t have an illness they clearly have”).

However, reference was
still made to “unhelpful beliefs”, to “the
relationship between thoughts, feelings, behaviours and
symptoms and the distinction between causal and
perpetuating factors” and to the fact that CBT would
include “identifying perpetuating factors that may
maintain CFS/ME symptoms” and would address “any
over-vigilance to symptoms”.

Research that indicates
potential dangers of the recommended management regime was
ignored and there was continued dismay that NICE again
highlighted CBT and GET as the most effective forms of
treatment.

Note: despite all
the biomedical evidence contained in the above documents and
the compelling scientific evidence that continues to mount
since they were written, NICE has still got CFS/ME
listed under mental health/behavioural conditions:

The process of bringing a
Judicial Review (JR) is costly and complex. Permission to
bring a JR has to be sought and obtained from the High
Court, which in itself is a significant hurdle. Obtaining
bullet-proof evidence to withstand rigorous legal scrutiny
is just the start. Finding suitably interested, competent
and committed lawyers to act for Claimants who are
effectively challenging a Department of State is a Herculean
task. Ensuring that those lawyers are fully briefed
and that they understand every aspect of the case is an
almost insurmountable undertaking before the case even gets
to Court. When the topic is ME/CFS, it is virtually
impossible. However, after an inordinate amount of
effort by many people, in 2008 Legal Aid was granted for
this to proceed.

Reasons for a JR of the
NICE Guideline included what has been addressed above in
relation to the NICE Guideline on CFS/ME, especially:

- NICE’s failure to
identify the disorder to which its Guideline purported to
apply

- The GDG’s refusal to
accept the WHO classification of ME/CFS as a neurological
disorder, which under NICE’s own protocol is mandatory in
the UK. NICE’s Progress Report No. 8 dated 18th
September 2002 from NICE’s Communications Director Anne Toni
Rodgers, which at the time was specifically drawn to the
attention of NICE’s Board, is unequivocal:

“2.7.1 Institute Classification
System

2.7.1.1. Following discussions
with Department of Health and other national agencies the
Institute has adopted a new classification system that
will be applied Institute wide

2.7.1.3 The previous
classification system was only used by the Institute

2.7.1.4 The ICD-10 classification
has been used as the basis for the new Institute
classification directed at the informed reader

2.7.1.5 The World Health
Organisation (WHO) produces the classification and ICD-10
is the latest version. ICD-10 is used within the acute
sector of the NHS and the classification codes are
mandatory for use across England”.

- the GDG’s failure of
procedure: because the intention of a NICE Guideline is to
influence clinicians (which immediately impacts on
patients), there are rigorous criteria that must be observed
in the production of a Guideline, but in the case of CG53
these were ignored

- NICE’s fabricated
statements about cost effectiveness of CBT/GET and there
were also mathematical errors in NICE’s figures and
statistics; (NICE’s statisticians transferred data from one
study to another to achieve the figures it wanted: since
even NICE could not procure non-existent evidence to support
its recommendations for behavioural therapy, it decided to
create its own evidence by transferring data from one study
and inserting that data into a totally different study to
produce what might have been the desired results if the
study in question had run for five years instead of only
fourteen months. The fact that the transplanted data came
from a study that had used different entry criteria and
whose own data had been corrupted (admitted by the authors
themselves) seems not to have troubled the Institute for
Clinical Excellence. Most straight-thinking people might
regard such doctoring of the evidence as fraudulent

- the proscribing of
testing and treatments that have been shown to help PWME

- the GDG’s failure to
consider the totality of the evidence, in particular, the
biomedical evidence: it was charged with providing guidance
on the diagnosis as well as the management of
CFS/ME, so the literature which demonstrates clear
biomedical pathology ought to have formed part of the GDG’s
literature review and not been specifically excluded from
the GDG’s remit (but of course that evidence would have
invalidated the behavioural research on which the use of
CBT/GET was based so they had to ignore it)

- the potential dangers
of the recommended interventions

- the rejection of
patients’ views and preferences

-
the deliberate refusal to have a medical expert experienced
in ME/CFS on the GDG as required

-
the bias of certain GDG members

- the covert conflicts of interest of some GDG members

- the fact that some GDG members were voting on studies that
they themselves had authored in support of the psychosocial
model

-
the GDG’s ignoring of the documented signs and symptoms in
ME/CFS and the demonstrated pathology of major body systems

-
the GDG’s ignoring of the existing evidence that CBT/GET are
both ineffective and harmful (especially if inflammation is
present)

-
the fact that even before the GDG started work, a policy
decision had been taken about the outcome

-
the fact that NICE is funded by and accountable to the
Department of Health, which formally accepts ME/CFS as a
neurological disorder yet NICE’s GDG refused to accept it as
such, which is inconsistent.

The Application
Hearing was heard on 17th June 2008 before The
Honourable Mr Justice Cranston and was successful: the
Approved Judgment stated:

"There is no doubt that ME is
a debilitating condition and many of us will know of
people who either have the condition, or who know of other
people who have the condition.....Given that there is this
obvious divide between the biomedical and psychosomatic
approaches to ME, given the great public interest....it
seems to me that this case ought to go forward for a full
hearing".

The Full Hearing was held
on 11th
and 12th
February 2009 before The Honourable Mr Justice Simon and it
failed on all counts. Before he became a Judge, Peregrine
Simon QC worked out of Brick Court, a leading set of
chambers that acts for the insurance industry against
claimants.

The Judgment was handed
down on 13th
March 2009. The Judge said that the Claimants’ evidence was
unconvincing, unreliable, unfounded and untrue, and entirely
without merit; the Claimants’ contentions could not be
sustained; their allegation that there was insufficient
representation of the biomedical approach was misconceived;
there was no conflict of interest among members of the GDG;
no GDG member had a closed mind about ME/CFS and GDG
members’ financial conflicts of interest (eg. working as
Chief Medical Officer for three insurance companies with a
financial interest in keeping CFS/ME excluded from benefits)
were not sufficient to preclude membership of the GDG and
the claim was seen to be baseless.

The Judge said the claim
contained the “vice” which was repeated against a number of
members of the GDG and that there was no bias among members
of the GDG (even though the known bias of the professional
members of the GDG was substantial and indisputable).

The Judge found that it
was not accepted by NICE that Professor Peter White was a
leading proponent of any particular view, and certainly not
the psychosocial model of “CFS/ME”.

The Claimants’ written
evidence that some GDG members had misled the High Court in
their Witness Statements was not heard (yet there are
criminal sanctions if there is evidence that someone has
made a false statement to the Court).

Furthermore, the
Claimants’ evidence that NICE’s lawyer (Charles Bear QC) had
misled the High Court was not heard (even though it was
substantiated in written evidence).

The Judge accepted all
NICE’s evidence and their experts’ Witness Statements
without equivocation (not every member of the GDG provided a
Witness Statement and some members provided more than one;
in total, there were 24 Witness Statements on behalf of
NICE.

Permission to appeal was
refused.

The outcome was a grave
miscarriage of justice and a legal travesty; it was also a
tragedy for patients with ME/CFS.

Following the Judgment,
Professor Peter Littlejohns, Clinical and Public Health
Director of NICE, announced in a Press Release:

“The Judge recognised the key
role that professionals have in contributing to the
development of NICE guidelines and therefore understood
the vigorous approach NICE took in defending these health
experts”.

What he actually meant by
the term “vigorous” was that less than 48 hours before the
case was to be heard, having seen the Claimants’ evidence in
full, NICE’s lawyers (Messrs Beachcroft LLP, who act for NHS
providers and commissioners) ambushed the Claimants’
solicitor and barrister with the threat of a career-damaging
“wasted costs” order, at which the Claimants’ lawyers
capitulated and – without consulting the Claimants (a gross
breach which itself initiated a professional negligence
claim that was upheld) they withdrew about 60% of the
Claimants’ evidence and apologised to the Court and to NICE.
Without the Claimants’ knowledge or permission, their
lawyers themselves submitted attenuated “evidence” (which
meant that the case could never have succeeded because so
much of the Claimants’ evidence about the failings of the
Guideline was not considered by the Court).

Notwithstanding, in July
2009 Mr Justice Simon ordered the Claimants’ solicitors to
pay NICE £50,000 damages in wasted costs as compensation for
what he ruled to be improper conduct of the case.

The JR challenge to
NICE’s Guideline on CFS/ME was pervaded by what has been
described as dishonesty, but it preserved State-sanctioned
“policy” at the expense of justice.

The Claimants stood no
chance against such powerful opponents who appear dedicated
to silencing the evidence which does not support “policy”.

On 28th
October 2006 the BMJ had carried an article and responses
that pertain to ME/CFS (“Vested interests will always trump
evidence”: BMJ 2006:333:912-915). One response from an NHS
Consultant was especially relevant:

“Over the past few
decades the practice of Medicine has moved from a basis of
personal experience and understanding of the disease
process and its treatment towards the application of
authorised protocols and guidelines. (The article)
raises concerns about the situation in which an inadequate
evidence-base has become canonised into established
guidelines, Government policy and incentivised practice”.

Nowhere has this been
more clearly demonstrated than in the NICE Guideline on
“CFS/ME”.

Some key documents pertaining to the JR

There was massive support
for the JR, not only from most of the ME charities
(excluding AfME and AYME) but also from individuals and
local support groups as well as medical scientists and
clinicians. The Claimant’s solicitor said : “Since
permission was granted in this case in June 2008…I have
been approached by a significant number of medical
practitioners and academics who are supportive of the
legal challenge and critical of both the Guideline and the
process which went into producing it”. From the many
received, the following professional Witness Statements were
submitted but were not permitted to be considered by the
Court [Note, some of these statements are available via the
links following this introductory text]:

- Dr Terry Daymond
(Consultant Rheumatologist; former Clinical Champion for ME
in North East England)

- Dr Charles Shepherd
(Hon Medical Advisor, the UK ME Association).

There were Witness
Statement of GDG members (on behalf of NICE); of the 15
professional members of the GDG, no less than 7 were
involved with Professor Anthony Pinching’s Service
Investment Programme for the implementation of the Clinical
Network Coordinating Centres (CNCCs or CFS Clinics) whose
remit was to deliver CBT and GET for “CFS/ME”. It is
therefore ludicrous to suppose that any of those 7 members
of the GDG would have voted against the recommendation of
CBT/GET.

There was also a Witness
Statement by Professor Anthony Pinching, who was responsible
for selecting the GDG members. Pinching was also involved
with the design the MRC PACE trial; the documentation
states: “The authors thank Professors Tom Meade, Anthony
Pinching and Simon Wessely for advice about design and
execution”. Thus there is evidence that Pinching
advised on a psycho-social trial which had “predictors”
that included “mood disorder, membership of a self-help
group (such as the ME Association), being in
receipt of a disability pension, focusing on physical
symptoms, and pervasive inactivity. CBT will be
based on the illness model of fear avoidance. GET will be
based on the illness model of deconditioning”.

It is notable that
although permission had been sought and granted by the Royal
Courts of Justice for the transcript of the JR hearing to be
placed in the public domain free of charge, the Judge
himself, Mr Justice Simon, specifically overturned that
permission and ruled that the hearing transcript should not
freely enter the public domain.

Extracts from The UK Government’s
three-pronged strategy for “CFS/ME”by Margaret Williams, 15th July 2014,
AMEA-Amended. Full text available at: